BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800218 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08733
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POCKET REVISION. THE REPORTER STATED THEY DID NOT KNOW THE REASON FOR THE REVISION AND THEY DID NOT HAVE ANY FURTHER DETAILS. THE DRUG IN THE PUMP IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HEALTHCARE PROFESSIONAL CUT OFF THE INFECTED SKIN FROM THE INCISION LINE ON (B)(6) 2014. IT WAS NOTED THE HCP THEN IRRIGATED THE WOUND WITH A COUPLE ¿LITERS¿ OF ANTIBIOTIC SOLUTION. IT WAS FURTHER NOTED THE HCP DID NOT OPEN THE POCKET DUE TO CONCERN THE INFECTION MAY SPREAD. THE REPORTER STATED THE PATIENT HAD REDNESS AT THE SITE AND THEY DID NOT KNOW IF THE PATIENT HAD A FEVER. THE REPORTER FURTHER STATED THE PLAN WAS TO OBSERVE THE PATIENT CLOSELY AND IF THE INFECTION SYMPTOMS RETURN THEN THE SYSTEM WILL BE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279377 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention